Drug for Sexual Desire Disorder in Women Works in Men, Too

SAN ANTONIO -- A drug approved for hypoactive sexual desire disorder (HSDD) in premenopausal women also improved sexual dysfunction in some men, according to a small dataset reported here.

Among 19 men with sexual dysfunction, 70% or more reported subjective improvement in multiple aspects of sexual arousal and activity with the dopamine modulator bremelanotide (Vyleesi). More men than women refilled prescriptions for the drug during follow-up for as long as 4 years, suggesting the drug was helpful for men with sexual dysfunction.

Notable side effects included nausea, often treated with concurrent ondansetron, and spontaneous erections without sexual stimulation, sometimes continuing intermittently for as long as 24 hours, reported Irwin Goldstein, MD, of San Diego Sexual Medicine, at the American Urological Association annual meeting.

"It was an observational study in our clinic, with lots of people using it, and it's been found to be helpful," said Goldstein. There are already symptomatic treatments for men with sexual dysfunction that act, in part, by maximizing smooth muscle relaxation, or muscle relaxation at a high level, which have a peripheral mode of action.

"The cool thing about [bremelanotide], and it definitely needs more study, is the CNS [central nervous system] method of action. We now have, theoretically, an opportunity to treat men with different sorts of strategies, the central nervous system and the peripheral nervous system," he noted.

Goldstein's wife and clinical research manager, Sue V. Goldstein, added that the treatment often resulted in multiple beneficial effects.

"We would ask a man to describe his sexual dysfunction and it might be an orgasm problem, which is a fairly common reason for prescribing it," she said. "We would ask whether the drug improved the orgasm problem, and they said yes. We asked whether it helped with erections, and they would say yes."

"So we might have prescribed it for one type of sexual dysfunction, but it actually helped across the spectrum. That's what I found most fascinating," she added.

Noting that the drug is an analog of α-melanocyte-stimulating hormone with an affinity for melanocortin-4 receptor, an unidentified member of the audience wondered whether men might have more receptors than women, potentially making bremelanotide more effective in men.

"I have no idea, but it's a fabulous opportunity to study it," said Goldstein.

In response to another question, Goldstein said most of the men had already tried conventional treatments without success, but many continued their existing treatment along with the bremelanotide subcutaneous injections.

Another unidentified member of the audience said he has prescribed bremelanotide for several years, and some patients have gotten better results by changing the treatment schedule. Rather than administer the drug before bedtime, they inject the medication 8 or 10 hours earlier in the day.

The FDA approved bremelanotide in June 2019 for premenopausal women with HSDD. The drug modulates dopaminergic pathways involved in sexual desire and arousal. Studies in women and men showed that the drug increases genital blood flow within hours after subcutaneous administration.

Soon after bremelanotide's approval, Goldstein began prescribing the medication off label for postmenopausal women and for men with different types of sexual dysfunction, as well as for premenopausal women. To get a better understanding of bremelanotide use in men and evaluate the drug's clinical effects, the Goldsteins analyzed bremelanotide prescription dispensing data for September 2019 through June 2023. They also studied men who had been prescribed bremelanotide for sexual dysfunction beginning in May 2021.

A subgroup of men completed a questionnaire that elicited information about sexual health, quality of life, global impression of improvement in sexual dysfunction, and general health status. The men also agreed to a structured interview by telephone.

Over the 46 months beginning September 2019, bremelanotide was prescribed 444 times for male sexual dysfunction, 104 times for postmenopausal women, and 76 times for premenopausal women. Refill rates were 65% for men, about 50% for postmenopausal women, and 40% for premenopausal women. For the 18-month period beginning May 2021, refill rates were 73% for men, 50% for postmenopausal women, and about 45% for premenopausal women.

Of 21 men who consented to the study, 19 completed the online questionnaire. More than 90% reported easier vaginal insertion during intercourse; about 80% or more reported improvement in partner's sexual experience, quality of lovemaking, anticipating that lovemaking would be more pleasurable and carefree, greater ease about initiating lovemaking, and satisfaction with lovemaking and duration; and about 70% or more found lovemaking more pleasurable and orgasm more pleasurable, and reported greater ease of orgasm.

The most commonly reported side effects associated with bremelanotide were flushing (36%), nausea (36%), headache (27%), bothersome spontaneous erections (27%), incontinence (9%), and abdominal burning (9%). All adverse events were transient.

"Some men had erections lasting a day, and they became panicky about priapism, but to the best of our knowledge, they had no erection problems after that prolonged erection," said Goldstein.

Sue Goldstein pointed out that the erections were not continuous for 24 hours, but rather lasted for a period of time, followed by a period without erection, and then followed by another period of spontaneous erection.

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